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The CoSeal™ Arterial Compression Band is a compression device that indicated to assist hemostasis of the radial artery after a transradial procedure, the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist. minimizing the loss of blood.

The CoSeal™ Arterial Compression Band ("CoSeal Band") is a hemostasis device which works by providing controlled compression on the radial artery without completely occluding blood flow or significantly compressing other structures. It consists of a Velcro belt attached with a balloon, and an injection port. The device also includes a separated syringe (inflator) for injecting air.The CoSeal band is a device that is sterile, for single use, and has a 24month shelf life with one adjustable wristband for different patient size.

Here's an analysis of the CoSeal™ Arterial Compression Band's acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria (e.g., "hemostasis in X% of cases," "leakage rate below Y%"). Instead, it states that the performance testing "demonstrated the safety and effectiveness of the CoSeal™ Arterial Compression Band is equivalent to the predicate devices." This implies the acceptance criterion was "equivalence to predicate devices" in the tested areas.

The reported device performance is qualitative, indicating successful completion of the tests.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for any of the performance tests (leak test, performance test, packaging, shelf life, sterilization, biocompatibility). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts or the establishment of ground truth for any of the conducted performance tests. These tests (leak, packaging, sterilization, biocompatibility, product stability) are typically laboratory-based engineering and material science tests, not clinical studies requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

As the performance tests described are laboratory-based and do not involve human interpretation of clinical data in the context of ground truth, an adjudication method (like 2+1, 3+1) is not applicable and therefore not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The studies described are performance tests of the device itself, not studies comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The CoSeal™ Arterial Compression Band is a physical medical device (hemostasis device), not an algorithm or AI software. Therefore, the concept of a "standalone" algorithm performance study is not applicable to this device. The performance tests conducted are inherently "standalone" in the sense that they evaluate the device itself.

7. Type of Ground Truth Used

For the performance tests listed:

• Leak Test, Performance Test, Packaging Performance, Product Stability (Shelf Life), Product Sterilization, Biocompatibility Testing: The ground truth for these tests would be established by engineering specifications, validated test methods, and industry standards (e.g., biocompatibility standards like ISO 10993, sterilization standards, packaging integrity standards). The tests themselves define what constitutes a "pass" or "fail" based on these established benchmarks. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. Since the CoSeal™ Arterial Compression Band is a physical medical device and not an AI/ML product, there is no training set in this context.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this device, this question is not applicable.

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